Oxycodone and Acetaminophen

Product NDC: 70010-669
11-digit product format: 700100669
Labeler code: 70010
Product ID: 70010-669_5d4f0bdc-289d-8606-e063-6294a90a354a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA211708
Marketing category: ANDA
Marketing start: 2022-01-01
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 7.5; 325 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211708-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31
A211708-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2019-10-31
A211708-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31
A211708-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2019-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211708-001	AA
A211708-002	AA
A211708-003	AA
A211708-004	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211708-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211708-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211708-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211708-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2019-10-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211708-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211708-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211708-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211708-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211708-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211708-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211708-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211708-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211708-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211708-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211708-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211708-004	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211708-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211708-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211708-003	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211708-004	AA	1	`79d66fd596c7…`
2019-12-13 00:20 UTC	2019-12	A211708-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211708-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211708-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211708-004	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211708-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211708-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211708-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211708-004	AA	1	`3f01610625f2…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211708-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211708-002	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211708-003	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211708-004	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone and Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	7.5 mg/1
ACETAMINOPHEN	325 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6	Product name	1	20170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
68d3ff71-7803-4cf4-ba84-71ce4712df22	Product name	1	20160620
07e5b999-fda7-79c9-8f77-8380537ade79	Product name	4	20160517
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70010-669-01	Oxycodone and Acetaminophen	100 in 1 BOTTLE	TABLET	100		18
70010-669-05	Oxycodone and Acetaminophen	500 in 1 BOTTLE	TABLET	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-669-01	EA - Each	70010-669	75adfaaa-b8e3-4ce9-9d57-4b9780ea855f	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-669	OXYCODONE AND ACETAMINOPHEN TABLET [GRANULES PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 2 package rows	20241107_cc966d57-7cdc-4de3-bbcf-718e2fce9cb7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049214	oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet	PSN	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049221	oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet	PSN	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049225	oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049635	oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet	PSN	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049214	acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SCD	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049635	acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet	SCD	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049221	acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049225	acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049214	APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SY	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049635	APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet	SY	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049221	APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SY	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18
1049225	APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SY	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70010-669-01	70010066901	100 TABLET in 1 BOTTLE (70010-669-01)	100 tablet	2022-01-01	No	No	Current
70010-669-05	70010066905	500 TABLET in 1 BOTTLE (70010-669-05)	500 tablet	2022-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets USP CII Rx Only	Granules Pharmaceuticals Inc.	2026-10-08	HUMAN PRESCRIPTION DRUG LABEL	19